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news.ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company and Bristol-Myers Squibb Company, have submitted a supplemental biologics license application to the FDA to broaden the use of Erbitux to include first-line treatment of patients with advanced non-small cell lung cancer in combination with platinum-based chemotherapy.
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The supplemental biologics license application (sBLA) submission is based primarily on data from the pivotal, multinational Flex Phase III study which demonstrated that the addition of Erbitux to cisplatin/vinorelbine significantly increased overall survival in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) when compared with cisplatin/vinorelbine alone.
Bristol-Myers Squibb is ImClone’s partner for Erbitux in North America. The FDA will notify ImClone whether it has accepted the submission for review in February 2009.
Maurizio Voi, executive director of oncology global medical affairs at Bristol-Myers, said: “The submission of the NSCLC application to the FDA further demonstrates the companies’ commitment to bringing innovative oncology treatments to people with cancer.”